TY - JOUR
T1 - Clinical efficacy and safety of oral Qing-Dai in patients with ulcerative colitis
T2 - A single-center open-label prospective study
AU - Sugimoto, Shinya
AU - Naganuma, Makoto
AU - Kiyohara, Hiroki
AU - Arai, Mari
AU - Ono, Keiko
AU - Mori, Kiyoto
AU - Saigusa, Keiichiro
AU - Nanki, Kosaku
AU - Takeshita, Kozue
AU - Takeshita, Tatsuya
AU - Mutaguchi, Makoto
AU - Mizuno, Shinta
AU - Bessho, Rieko
AU - Nakazato, Yoshihiro
AU - Hisamatsu, Tadakazu
AU - Inoue, Nagamu
AU - Ogata, Haruhiko
AU - Iwao, Yasushi
AU - Kanai, Takanori
N1 - Publisher Copyright:
© 2016 The Author(s) Published by S. Karger AG, Basel.
PY - 2016/6/1
Y1 - 2016/6/1
N2 - Background/Aims: Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. Methods: The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. Results: At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. Conclusion: This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.
AB - Background/Aims: Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. Methods: The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. Results: At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. Conclusion: This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.
KW - Aryl hydrocarbon receptor
KW - Chinese herbal medicine
KW - Colon
KW - Indigo naturalis
KW - Indole
KW - Inflammatory bowel disease
KW - Interleukin-22
KW - Qing-Dai
KW - Ulcer healing
KW - Ulcerative colitis
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U2 - 10.1159/000444217
DO - 10.1159/000444217
M3 - Article
C2 - 26959688
AN - SCOPUS:84961206100
VL - 93
SP - 193
EP - 201
JO - Digestion
JF - Digestion
SN - 0012-2823
IS - 3
ER -